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Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by: Glenmark Pharmaceuticals Inc., USA, Elmwood Park, NJ 07407, NDC 68462-626-52.

CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.

Class II Medicine & devices FDA August 5, 2026 Reached Texas
Read the official FDA notice →

What to do

Stop using the product and check it against the description above. Follow the remedy on the official notice; most recalls are refunded or replaced without a receipt. If you or a family member has already been affected, keep the packaging and the lot code — they're what a claim rests on later.

Details

Recalling company
Glenmark Pharmaceuticals Inc., USA — Elmwood Park, NJ
Severity
Class II — moderate
Reported
August 5, 2026
Quantity
N/A
Recall number
D-0731-2026
Status
Ongoing
Source
FDA

Where it went

Nationwide within the United States.

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